ELTAMD UV PHYSICAL SPF41- zinc oxide and titanium dioxide sunscrreen lotion 
CP Skin Health Group, Inc.

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EltaMD UV Physical SPF41

Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 9.0%   Sunscreen
Titanium Dioxide 7.0%   Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Uses

Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at lest every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time int he sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

Alumina, Butylene Glycol, Citric Acid, Iodopropynyl Butylcarbamate, Iron Oxide, Isopropyl Palmitate, Lecithin, Linoleic Acid, Hydrogen Dimethicone, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, Perfluorononyl Dimethicone, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polysorbate 20, Purified Water, Quercitin, Sodium Hydroxide, Thioctic Acid, Triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN 

KEEP OUT OF REACH OF CHILDREN 

Labeling

UV Physical UC_Page_1

ELTAMD UV PHYSICAL SPF41 
zinc oxide and titanium dioxide sunscrreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2578
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
QUERCETIN (UNII: 9IKM0I5T1E)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2578-385 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2578-22 g in 1 PACKET; Type 0: Not a Combination Product07/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/10/2018
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2578)

Revised: 11/2023
Document Id: 6e5791ac-2a4b-458c-bd5e-e34dc048c801
Set id: 2900b117-ff98-42e6-a2fc-2cd89d14ee6e
Version: 5
Effective Time: 20231109
 
CP Skin Health Group, Inc.